ABOUT THE NEST
At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We’re 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.
This position can be based anywhere in Italy
Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. The focus of this position is to support Apheresis Operations group within bluebird bio to enable the growing network of Clinical and Commercial Apheresis Collection Centers and Cell Therapy Labs. We are looking for an innovative professional with the breadth of experience and drive to implement our vision for this function and work collaboratively across bbb.
This role will provide both clinical and commercial sites pre-boarding and onboarding training, scheduled apheresis collections, and site monitoring support. As a headquarters-based team member, you will be a part of several projects, cross-functionally collaborating with CMC, Non-clinical, Clinical, Manufacturing, QA, Supply-Chain, Commercial, and administrative areas. This position provides an excellent opportunity to gain experience and learn broad aspects of gene therapy regulations.
About the role:
- Work with the Director, Apheresis Operations, and Italy’s General Manager or designee, to oversee the administrative and operational aspects of apheresis collections and product development.
- Conduct clinical & commercial site onboarding activities including site training, scheduled apheresis collections, and site monitoring functions.
- Partner with quality during the quality audit to perform routine technical assessments at the clinical and/or commercial sites.
- Provide apheresis expertise to support various internal activities such as regulatory submissions, protocol development, and other quality processes.
- Partner with clinical, quality, supply chain, and commercial teams to build a sustainable collection network for clinical trials and commercial operations.
- Work with commercial personnel to promote and coordinate commercial business plan
- Participate in clinical & commercial site qualification visits for training and method transfer.
- Work independently to ensure that contracted facility collection functions are current as to equipment, training and technology according to internal procedures and recommendations.
- Contribute to the development and maintenance of procedures related to standard cell procurement and apheresis practices, within Apheresis Operations team.
- Provide technical feedback and guidance on optimizing collection procedures, or impact of collection procedures on further manufacturing.
- Work closely with the Supply Chain department to ensure traceability of apheresis product for clinical and commercial manufacturing.
- BS/MS or RN degree/equivalent, with strong apheresis experience required (5+ years).
- Experience in Bone Marrow / Stem Cells Transplantation preferred.
- Willingness to travel, domestically and some internationally (~30% of time).
- Flexibility needed due to patients’ apheresis collection schedules.
- Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals.
- Strong verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately.
- Independently motivated, detail oriented and good problem-solving ability.
- Good understanding of applicable regulations and standards (FDA/EMA, AABB, FACT/JACIE, GMP, GCP, etc.)
- Ability to successfully manage multiple projects
- Ability to foster positive relationship with assigned Apheresis Collection Centers and Cell Therapy Labs
- Fluent English, Italian, and addition languages would be an advantage.
To all recruitment partners: bluebird bio does not accept resumes. Please do not forward resumes to our jobs alias, our birds or any other organization location. bluebird bio is not responsible for any fees related to unsolicited resumes.
All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.
bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.
bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.